31 results · 29ms · Sources: EU EUDAMED, US FDA

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ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1

FDA Recall
Completed ·Varian Medical Systems Imaging Laboratory GmbH Tafernstrasse 7 DATTWIL Baden Switzerland·Product code IYE·March 21, 2022

NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software

FDA Recall
Completed ·Illumina, Inc.·Product code PFF·April 5, 2023

MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.

FDA Recall
Completed ·Illumina, Inc.·Product code PFF·April 5, 2023

Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850

FDA Recall
Completed ·Beckman Coulter, Inc.·Product code CDD·February 27, 2025

Endoscopic Curved Intraluminal Stapler, 25 mm diameter, Model ECS25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility.

FDA Recall
Completed ·Ethicon Endo-Surgery Inc·Product code GDW·April 11, 2019

Endoscopic Curved Intraluminal Stapler, 21 mm diameter, Model ECS21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility.

FDA Recall
Completed ·Ethicon Endo-Surgery Inc·Product code GDW·April 11, 2019

Endoscopic Curved Intraluminal Stapler, 29 mm diameter, Model ECS29A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility.

FDA Recall
Completed ·Ethicon Endo-Surgery Inc·Product code GDW·April 11, 2019

Endoscopic Curved Intraluminal Stapler, 33 mm diameter, Model ECS33A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility.

FDA Recall
Completed ·Ethicon Endo-Surgery Inc·Product code GDW·April 11, 2019

Straight Intraluminal Staplers, 33 mm diameter, Model SDH33A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility.

FDA Recall
Completed ·Ethicon Endo-Surgery Inc·Product code GDW·April 11, 2019

Curved Intraluminal Staplers, 29 mm diameter, Model CDH29A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility.

FDA Recall
Completed ·Ethicon Endo-Surgery Inc·Product code GDW·April 11, 2019

Curved Intraluminal Staplers, 21 mm diameter, Model CDH21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility.

FDA Recall
Completed ·Ethicon Endo-Surgery Inc·Product code GDW·April 11, 2019

Straight Intraluminal Staplers, 21 mm diameter, Model SDH21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility.

FDA Recall
Completed ·Ethicon Endo-Surgery Inc·Product code GDW·April 11, 2019

Straight Intraluminal Staplers, 25 mm diameter, Model SDH25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility.

FDA Recall
Completed ·Ethicon Endo-Surgery Inc·Product code GDW·April 11, 2019

Curved Intraluminal Staplers, 25 mm diameter, Model CDH25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility.

FDA Recall
Completed ·Ethicon Endo-Surgery Inc·Product code GDW·April 11, 2019

Straight Intraluminal Staplers, 29 mm diameter, Model SDH29A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility.

FDA Recall
Completed ·Ethicon Endo-Surgery Inc·Product code GDW·April 11, 2019

Curved Intraluminal Staplers, 33 mm diameter, Model CDH33A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility.

FDA Recall
Completed ·Ethicon Endo-Surgery Inc·Product code GDW·April 11, 2019

Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838

FDA Recall
Completed ·Cook Incorporated·Product code DQY·May 25, 2022

Illumina NextSeq 550Dx, REF: 20005715, CE, IVD

FDA Recall
Completed ·Illumina, Inc.·Product code PFF·February 22, 2022

Leccurate SARS-CoV-2, Antigen Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for the qualitative detection of antigen SARS-CoV-2 in clinical samples (nasal swab).

FDA Recall
Completed ·LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD Building 7-1 NO. 37 Chaoqian Rd; Changping Tech Zone Beijing China·Product code QKP·April 26, 2021

iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System

FDA Recall
Completed ·Boston Scientific Corporation·Product code DQK·September 18, 2019